Nasal Tea Tree Oil for the Prevention of Infections in PD Patients (NCT01214395) | Clinical Trial Compass
CompletedPhase 2
Nasal Tea Tree Oil for the Prevention of Infections in PD Patients
Australia5 participantsStarted 2010-06
Plain-language summary
This study will compare the use of tea tree oil as a topical nasal antiseptic to prevent infections in patients that need renal dialysis. A maximum of fifty subjects will be recruited and will be assessed for signs of infection once per week for the first 6 weeks and then every 4 weeks until week 26. They will also be checked for nasal carriage of 'Golden Staph' when they enroll in the trial. The subjects will complete the trial if they have 26 weeks infection-free or if they have an infection during that period
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Men or women over 18 years of age
* A signed and dated written informed consent is obtained prior to participation.
* Able to comply with the requirements of the protocol.
* Have ESRD and dialysis is planned
* Requirement either haemodialysis or peritoneal dialysis
Exclusion Criteria:
* known sensitivity to TTO
* Use of mediated and non-medicated nasal ointments in the past 12 weeks
* HD patients likely to transfer to a another dialysis centre in the next 6 months
* Re-insertion of CVC
* serious, uncontrolled disease (including serious psychological disorders) likely to interfere with the study and/or likely to cause death within the study duration
* participation in another clinical trial during the last 12 weeks
* previous participation in this trial
* known contraindication to any component of mupirocin
* concurrent diseases which exclude the administration of therapy as outlined by the study protocol
* active infections requiring systemically administered antibiotics or antiviral medications within the last 7 days
* acute renal failure
* non-compensated heart failure
* myocardial infarction during the last 6 months
* chronic lung disease with hypoxemia
* severe non-compensated hypertension
* severe non-compensated diabetes mellitus
* known HIV or active chronic hepatitis B or C infection
* subjects who, in the opinion of the investigator, are not likely to complete the study for what ever reason.
* subjects who, in the opinion of the investigator,…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Primary Endpoint Will be the Number of Tea Tree Oil Patients That Did Not Have a Catheter-related Infection Within 6 Months After Entry Into the Trial.